XL184

I don't have a lot of info on xl184, but know a lot of guys on xofigo with good results....it's like a smart bomb for bone mets...

I think I read that XL184 cleared or reduced bone mets in an early trial. There were a couple of pulmonary embolisms, but think they adjusted the dose because of that.
Anyway, good luck with his treatments.

Hi Ann,

I think cabozantanib (XL-184 or Cometriq) is probably the most promising new drug in clinical trials. It's already been approved for medullary thyroid cancer. It has been known to completely clear radiological evidence of bone mets in some men in as little as 12 weeks.

The advantage of the trial against Mitoxantrone is that he is assured of getting at least something that has worked, even if he doesn't get the cabozantanib. The downside is mitoxantrone is usually less effective than the newer chemo drugs: Taxotere and Jevtana.

If travel is a problem for a 2-hr drive, I suppose a 4 hr drive is out of the question? With the 2-hr drive, he risks being in the placebo group. With a 4 1/2-hr drive to Ann Arbor, MI, it's a Phase II study in which he's assured of getting the drug. With a 4-hr drive to Detroit, it's a pilot study in which he is assured of getting the drug, and he gets a fancy PET scan to boot. The drug company typically picks up the tab and sometimes covers travel, expenses and may pay an honorarium. Here's the info:

Trial of Cabozantinib (XL184) in Castrate-Resistant Prostate Cancer Metastatic to Bone at UMich

Cabozantinib-S-Malate in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer at Karmanos Cancer Inst, Detroit

- Allen

I was given the consent form for this trial at Karmanos last fall. It does require numerous trips to Detroit for tests/ blood work,especially in the first month. Then every 2-4 weeks there after. As usual it comes with a long list of possible side effects. Depending on my next round of scans,I may be looking at this or possibly Xtandi after I complete provenge on feb 14th. I thought I read somewhere that it also worked well on soft tissue as well??

Many thanks, as always, Tall Allen, for all the information. Thanks especially for the comparison of the studies being done here in Toronto and in London, ON. You have helped clarify that choice in my mind.

Yes, it would be good to know that he was taking something that was working against the cancer, even if not the XL184.
Perhaps Mitoxantrone is not as effective as Taxotere but hopefully the side effects are less.
There was a post in HW by Arno on the study comparing mitoxantrone vs docetaxel done in Toronto by Dr Tannock. It was entitled Did anyone listen?

Here is a little from it....
<<<<As dr. Tannock said: the modest gain in median survival (2-3 months) obtained with docetaxel needs to balanced against the side-effects and cost of the treatment. And actually, the claim of a longer survival time is questionable as well. The uncertainty in its value (2-3 months) is probably something like 1.5 months (the weekly docetaxels' gain was 1.5 months, and that said to be not significantly different from zero).

Comparing the side-effects of the treatment with Taxotere vs that with mitoxantrone: diarrhea happened for 32% vs 10% of the patients, fatigue: 53 vs 35%, loss of hair: 65 vs 13%, etc.. And there were more than 1 serious adverse events experienced by 29% of those treated with Taxotere vs by 20% of those treated with mitoxantrone.>>>>

John did 3 sessions with Docetaxol last spring and his PSA did drop significantly but he hated the way he was feeling. He said life was not worth living if he had to feel that sh****. He then went on Xtandi (PSA dropped a lot again) which worked for about 3 months. Now on Zytiga.

As for the trials in Ann Arbor and Detroit.... Travel there is out of the question for a couple of reasons. First of all, he is not well enough for the trip which could include long waits at the border as well as approx 4 1/2 hours driving each way. Secondly, we dare not enter the US because he cannot get insurance that would cover any medical problems/emergencies resulting from pre-existing conditions. Any emergency medical care he might need would bankrupt us!

I am still looking for information from those who were in the trials as to side effects. However, I know that individuals vary greatly on that score. All information greatly appreciated!

Many thanks again, Ann

Just so everyone understands:

Cabozantinib is marketed under the tradename, Cometriq, formerly known as XL184....Cabozantinib was approved by the U.S. FDA in 2012 for thyroid cancer.  It is currently in clincial trials for several cancers, including PC.

Zimac - was he prescribed this for PC?

Zimac,

Can you share what the cost was? Exelexis originally announced it would cost $10,000 for a one month supply. Did insurance cover it?

- Allen

Zimac,

That's great! For me, your experience stands as a good lesson about dealing with insurance - one never knows unless one tries first. I always ask for pre-approval (I've been burned before).

- Allen

Hi, I'm back again. Unfortunately the trials are out of the question as John's hemoglobin has fallen. It was 7.2 and he received 2 units of blood Feb 8. It was 8.4 Feb 27. Oncologist will find out if John would be eligible if hemoglobin was artificially raised ie through blood transfusion. Anyone know? I think it needs to be 9.0.

Failing that, it looks like the only remaining option is Mitoxantrone to relieve pain and improve quality of life. I am wondering what experiences the guys have had. Are the side effects worth it?

We are in Canada and our insurance does not cover much beyond what the government will pay.

John had spot radiation on Thursday for pain in the leg. We will see how pain is once the flare is over....a few days. He has done very well pain-wise with spot radiation in the past.

He is continuing on Zytiga - perhaps it is slowing progression.
Jan 9 - 619
Feb 6 - 509 only change was switching from 2 x 5 mg/d prednisone to 1 x 0.5 Dexamethasone.
Feb13 - 522
Feb 27 - 582

Any advice gratefully received! Ann

Good question. I don't know. I just asked about whether he would be accepted if Hg was artificially raised. Oncologist said he would look into it but didn't think so. Will ask again in 2 weeks. And mention erythropoietin too. I don't know it but will look it up.

Up until now, John did not qualify for the trial because he did not have enough pain to require him to use regular ie 2x 10 mg long acting per day. In the past 2 weeks he has had more pain but mostly been taking morphine at night when it is bad. Now that he has had spot radiation that may improve. We will see.

It wouldn't be too difficult to take the 2 LA morphine to get into the study if blood tests were OK.

Thanks, Ann

It is a Study of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer (COMET-2).

I will try to see what Hg needs to be. Good to know that some trials allow boosting Hg.

Ann

Problem is that we are in Canada and don't have insurance that would cover it....and government is not yet paying for it. It is otherwise rather expensive. Ann